Pharmaceutical Executive-03-01-2004

In 1996, Sandoz (now Novartis) decided to brave new waters to create consumer demand for the antifungal Lamisil (terbinafine) in the United Kingdom. But with European law forbidding pharma companies to conduct brand-name advertising, Sandoz needed to find another way to encourage patients to talk with their doctors about onychomycosis and its treatment options. So the company re-named the condition the more consumer-friendly "fungal infection" and took out newspaper ads asking readers to call or write to "Step Wise" for a free brochure on foot care.

For a patient who is running out of hope, waiting for a drug to be approved can be interminable. Even on the fast track, a review can take six months or longer. Some patients with life-threatening diseases cannot afford to wait. In response, many countries have developed expanded access programs (EAPs) that give patients with no other viable alternative access to medically important drugs before they are commercialized.

Pfizer is embroiled in a whistleblower lawsuit based on an unproven legal theory with the potential "to scare the hell out of a lot of drug companies," says attorney Alan Minsk of Arnall Golden Gregory. If upheld, even those compliant with FDA regulations for off-label promotion might still be liable for Medicaid fraud under the federal False Claims Act (FCA).

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Antiquated manufacturing processes cost pharma money-a fact widely known and accepted in the industry. At some facilities, rejected batches, rework, and lengthy investigations have become a way of life, and by some estimates can inflate production costs by as much as 10 percent. According to G.K. Raju, executive director of the Pharmaceutical Manufacturing Initiative at the Massachusetts Institute of Technology, manufacturing consumes an estimated 25 percent of drug company revenues.